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Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.
Your Role
The cGMP Principal Production Scientist is recognized as a highly technical individual contributor within the cGMP Manufacturing organization, but expected to provide leadership to on the floor operations. This position is responsible for the execution of high-profile and high-impact projects which will include technical transfer of new APIs, process optimization of existing products, identifying new innovative ways of working, and key infrastructure projects to improve the capabilities within cGMP Manufacturing as well as the across the site. The cGMP Principal Production Scientist interfaces regularly with support teams as well as internal/external customers; the role also serves as a mentor to other Staff Scientists and colleagues within the organization. This position will not have any direct reporting structure, but is expected to lead manufacturing teams with projects, manufacturing, safety, and documentation oversight activities.
This position requires a very sound technical and quality background. Direct interaction with Process Development, Quality Assurance, Quality Control, Validation, Project Management and customers is expected, therefore, good communication skills (oral and written) are essential. Customer and Regulatory audit support is expected.The Principal Production Scientist must have the ability to apply and incorporate pharmaceutical standards and rules, as per ICH Q7, into documents and day-to-day practice.The Principal Production Scientists are expected to identify potential safety, quality and compliance risks associated with technology transfer and scale-up, and propose solutions to mitigate risk prior to GMP Manufacturing operations. The Principal Production Scientists will serve as the technical manufacturing lead on pilot scale and full scale manufacturing of new APIs. Responsibilities include:Review and approvals for first in-in-plant cGMP batch records and automation recipes.Communicating the status of operations to departmental leadership and the customer.Providing ad-hoc oversight for shift operations as backup to supervision. Managing ad-hoc projects to improve production efficiency, departmental quality/safety compliance, and site operations.Coordinating and delegating all tasks and responsibilities associated with GMP Manufacturing operations.The principal production scientist will support customer and regulatory audit events, with direct interface with auditor.The principal production scientist must possess demonstrated skills in the investigation and documentation of process deviations and corrective actions.The principal production scientist will aid in the assessment and implementation of process changes, originating internally and externally from the manufacturing group.Customer interaction adds an additional element to this position. The customer judges our Company based on interactions with our employees, deciding if continual business opportunities will be offered to MilliporeSigma. This element adds an additional challenge to the employee in this position to represent MilliporeSigma with the highest level of professionalism and responsibility.Serve as a senior technical lead on major development projects, including direct customer interaction.Serve as department lead on infrastructure improvements (Facility improvements, Manufacturing/Cleaning philosophy improvements, etc.)Assist Manufacturing staff in troubleshooting and provide effective/innovative solutions for challenges in manufacturing arenasA proactive role model for continuous improvement and innovation in process development science and technology, including cost reduction and yield improvement.Provide on-the-floor training and mentor other Staff Scientists within the cGMP Manufacturing organization.Remain current in field of expertise through reading the literature and/or attending scientific meetings and seminars.fAct as a recognizable scientific resource across departments.Demonstrate a broad range of scientific knowledge including a strong understanding of production processes and technologies.
Who You Are
Minimum Qualifications:
B.S. in Life Science or Engineering (10 years manufacturing experience) in cGMP manufacturing or technical support role (R&D or technical transfer position directly associated with manufacturing opportunities). Advanced degree (Masters, PHD) and at least 6 years manufacturing experience in cGMP manufacturing or technical support role (R&D or technical transfer position directly associated with manufacturing opportunities).Intermediate to advanced knowledge in chemistry, biology, biochemistry, and math, as well as full understanding of current Good Manufacturing Practices is required.Familiarity with analytical instrumentation and cGMP process equipment is required. Typical equipment interfaces includes DeltaV, Unicorn, CCP6.This role requires a working knowledge of Microsoft Office based programs for Manufacturing/Operating procedure writing, technical report generation, product tracking and trending data analysis and Operational Excellence reports.Preferred Qualifications:
Experience with environmentally controlled manufacturing suites required (clean rooms).Process and automation troubleshooting and analysis required.Proven experience with customer interface, such as CDMO operation.Proven experience with regulatory and quality organizations.
Work Environment/Physical Attributes
This role is on-site. This role is expected to be primarily 1st shift (Monday-Friday). However, this role will support flexible shift patterns (including weekend and off shift schedules) as backup to primary supervision.Manufacturing is performed in clean rooms (ISO and EU) with potentially high potent compounds, requiring specific PPE, such as respirators and chemical protective clothing for extended periods.No significant travel is expected.Ability to lift up to 50 pounds.
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
Apply now and become a part of our diverse team!
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